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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL, INC., SUB. C.R. BARD, INC. CR BARD MESH PLUG MESH, SURGICAL, POLYMERIC

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DAVOL, INC., SUB. C.R. BARD, INC. CR BARD MESH PLUG MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number FALSIFIED ON SURGICAL REPORT
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Aeromonas hydrophila (b)(6) seafood chowder counterfeit mesh by (b)(6). This is an add on to the report i just submitted because it does not appear that you took my email i see (b)(6) was there when this was initially reported, i have no problem saying hhs/fda-oig cover up makes him culpable. Refer to us doj criminal prosecutions or (b)(6); he puts judges in prison too. So does (b)(6) (ref, (b)(6)). (b)(6) is lawyer and a politician-that makes this form nothing more than data collection- he¿s not my representative, my advocate and his education makes him evil. So forward to potus and tell him this is no different than the tree of life shootings; i think the shooter is getting death row. I expect the same. Fda oig already gave my name to manufacturer; resulted in terroristic threats, obstruction of justice, witness tampering (threats to me are recorded as evidence) do not do it again or you¿ll sec of hhs also be included in this case. Food (b)(6) seafood chowder; device-crbard mesh plug&panel (falsified). (b)(6) fish market; cr bard davol. Cascade of deleterious effects from no consent counterfeit mesh; it¿s an endocrine system disruptor. Spinal cord injury from ¿cover up-perpetrators¿. No prescription meds (can¿t digest enteric coatings); medical implant not completely explanted (your crime; not mine). I believe your agency is copying me- you have to pay for it which is why i expect (b)(6) to be indicted. Fda safety report id # (b)(4). Fda received date 02/17/2020.
 
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Brand NameCR BARD MESH PLUG
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL, INC., SUB. C.R. BARD, INC.
MDR Report Key9753287
MDR Text Key181408195
Report NumberMW5093265
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFALSIFIED ON SURGICAL REPORT
Device Catalogue NumberFALSIFIED ON SURGICAL REPORT
Device Lot NumberFALSIFIED ON SURGICAL REPORT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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